Resource Center 中文

The WFI storage and distribution SKID features professional modular 3D design, which is characterized with reasonable and compact structure, pleasant appearance, convenient daily maintenance and operator-friendliness. According to the actual requirements of clients and the operation mode of different dosage forms, the system can be designed for various operation modes, such as high temperature storage and high temperature circulation, high temperature storage and low temperature circulation, low temperature storage and low temperature circulation, with the purpose to conserve energy and reduce emissions. The system can be designed with multiple sterilization modes, such as pure steam sterilization or 121℃ superheated water sterilization. The pumps, heat exchangers, valves, pipes, instruments and other main components selected for the equipment are all well-known brands around the world, which can ensure the stable operation of the system in a long term. The program is optimized in accordance with GAMP5, which improves the stability of the program and complete documentation system to ensure the traceability of the system. To check whether the WFI system can stably produce WFI that meets the quality requirements in various circumstances in the future, the system will be subjected to the main verification and testing activities including risk assessment (RA)/Design Qualification (DQ)/Installation Qualification (IQ)/Operation Qualification (OQ). The system can fully meet the requirements of FDA cGMP, EU GMP, WHO GMP and SFDA GMP.

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